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A multicentre, real-world study on the analysis of factors related to sustained treatment with domestically produced paliperidone palmitate injection

A multicentre, real-world study on the analysis of factors related to sustained treatment with domestically produced paliperidone palmitate injection

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092854
Enrollment
Unknown
Registered
2024-11-25
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

schizophrenia

Interventions

Schizophrenia group:Continuous treatment with national paliperidone palmitate injection

Sponsors

Chaohu Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Outpatients or inpatients with schizophrenia meeting ICD-10/11 diagnostic criteria; (2) Aged 18-65 years (including the lower boundary value), with no gender restriction; (3) Subjects or their guardians sign an informed consent form

Exclusion criteria

Exclusion criteria: (1) Patients have a diagnosis of a psychiatric disorder other than schizophrenia; (2) Those with severe somatic diseases, mental retardation, mental disorders due to organic brain and somatic diseases, or other indicators of abnormality (AST/ALT = 2 times the upper limit of normal value, Cr > 1.2 times the upper limit of normal value, and QTc intervals > 450ms in men and > 470ms in women); (3) Those with a history of psychoactive substance abuse (other than tobacco) in the past 12 months, significant suicidal or violent behaviour; (4) Those with a history of or current delayed dyskinesia (TD), antipsychotic-induced malignant syndrome (NMS), or severe extrapyramidal adverse effects; (5) Those who have had a previous allergic reaction to any antipsychotic drug; (6) Those who have failed previous treatment with risperidone or paliperidone; (7) Pregnant or breastfeeding women or those who plan to become pregnant; or those who cannot be assured of effective contraception for the duration of the study; (8) Any other condition that, in the opinion of the investigator, makes the patient unsuitable for clinical research

Design outcomes

Primary

MeasureTime frame
clinical symptoms;Adverse reaction;

Countries

China

Contacts

Public ContactHuanzhong Liu

Chaohu Hospital of Anhui Medical University

huanzhongliu@ahmu.edu.cn+86 138 5515 2219

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026